Complaint Specialist - San Diego, United States - The University of Texas MD Anderson Cancer Center

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    Description

    Job Title:
    Complaint Specialist

    Job Number:

    34540

    Location:

    12390 El Camino Real San Diego,CA 92130

    Job Description

    Responsibilities


    Conducting complaint investigations and associated tasks to ensure complaint investigations are thorough, investigation conclusions are appropriate, appropriate procedures are followed, and complaint investigations are conducted and closed in a timely manner.


    Reviewing & identifying the root causes of complaints and works with the applicable operational departments such as: Product Development, Manufacturing Engineering, and Quality Engineering to ensure an appropriate resolution.

    Responding directly to customers to investigate and resolve complaints, when necessary.

    Assisting in the development of training materials and process enhancements related to complaints management.

    Facilitating complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection/investigation, as needed.

    Participate in quality management system meetings regarding complaints and complaint handling.


    Performing duties in accordance with the Company's Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.

    Providing input to support the continual improvement of complaint handling processes.

    Performing other related duties as assigned.

    Required Skills

    Strong computer skills.

    Proficiency with Microsoft Office business software and use of information databases

    Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance

    Proven ability to communicate effectively; orally and written

    Ability to manage multiple tasks and projects

    Able to work independently, as well as in a cross-functional team environment

    Customer service oriented attitude and ability to exercise sound business judgment

    Ability to maintain confidentiality and discretion in business relationships

    Able to define problems, organize and collect data, establish facts, and draw valid conclusions

    Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus

    Travel between sites as needed

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